Polypectomy Snare
FDA 510(k) K221713 · Hangzhou AGS MedTech Co., Ltd.
510(k) numberK221713
Submission
- Device name
- Polypectomy Snare
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
Hangzhou, CN - Received
- June 13, 2022
- Decision date
- March 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254069 | Hemoclip (511 series, 543 series)PKL · Traditional | 08/10/2026SE |
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| K252270 | HemoclipPKL · Traditional | 04/08/2026SE |
| K252271 | HemoclipPKL · Traditional | 11/12/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | 03/20/2025SE |
| K222421 | SphincterotomeKNS · Traditional | 05/03/2023SE |
| K213143 | HemoclipPKL · Traditional | 07/12/2022SE |
| K213578 | Balloon Dilatation CatheterFDF · Traditional | 04/06/2022SE |
| K211787 | HemoclipPKL · Traditional | 03/03/2022SE |
| K210406 | Bipolar Coagulation ForecepsKGE · Traditional | 10/05/2021SE |
Questions and answers
When was Polypectomy Snare cleared by the FDA?
Polypectomy Snare (K221713) received a 510(k) decision of Substantially Equivalent on March 3, 2023, 263 days after the submission was received.
What is the product code of K221713?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.